Chagas disease is a neglected tropical disease caused by the protozoan Trypanosoma cruzi and spread through the triatomine bug. The World Health Organization estimates that nearly six million people are infected with T. cruzi in Latin American and seventy million people are at risk of infection, which can cause cardiac and intestinal complications. If untreated, infection is lifelong and can be life threatening. Morbidity and mortality from Chagas disease is a critical health problem affecting poor communities throughout Latin America.

The WHO has put forward goals for the interruption of transmission in the home (Latin America) and through blood transfusions (Latin America, Europe, and Western Pacific) by 2015, as well as the elimination of Chagas-carrying insects near homes in Latin America by 2020. The London Declaration on NTDs backed these goals with commitments from public and private institutions. However, according to the London Declaration 3rd Report, more concerted efforts to improve access to diagnosis and treatment are needed to achieve these goals.

PATH aims to catalyze engagement of the diagnostics industry and product development efforts in support of the London Declaration goals. As part of this work, PATH examined the Chagas diagnostics landscape to identify gaps in availability, accessibility, and use of appropriate diagnostic tools for Chagas. We conducted literature reviews and interviews with key stakeholders to identify use cases for Chagas diagnostics, understand current practices, and assess progress toward more robust diagnostics. The findings were used to analyze the current diagnostic landscape for Chagas and highlight current needs to improve access to diagnostics for prioritized use cases.

PATH identified four use cases for Chagas diagnostics: case diagnosis, congenital case detection, treatment monitoring, and screening of blood and organ donations. Our analysis found that access to and adoption of current tools remain a barrier to their effective use in Chagas disease control efforts in many endemic settings. This may be due in part to insufficient evidence to support their implementation. Additionally, because of the reliance on serologic tests and inadequate markers of active infection, current tools available to detect congenital infections and monitor treatment are not yet sufficient to fully support needs in these use cases. Based on these findings, we offer the following recommendations:

1. Establish more standardized policies and practices for Chagas diagnosis and treatment by generating evidence around the efficacy of current tools in diverse settings and building consensus around standards among global and regional stakeholders.
2. Develop a point-of-care diagnostic tool to detect congenital infections, which would enable early initiation of treatment and a clear linkage to postnatal care.
3. Develop a diagnostic tool to monitor treatment efficacy, which would inform clinical decision-making during treatment and support the development of better drugs.